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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K200469
Device Name PAPAYA 3D Premium & PAPAYA 3D Premium Plus
Applicant
Genoray Co., Ltd.
#512, 560, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13230
Applicant Contact Hyunju Hwang
Correspondent
Genoray America, Inc.
147 E. Bristol Lane
Orange,  CA  92865
Correspondent Contact Kaitlynn Min
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received02/26/2020
Decision Date 09/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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